1 the gracia – 2 trial (grupo de análisis de la cardiopatía isquémica aguda) randomised trial...
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The GRACIA – 2 TrialThe GRACIA – 2 Trial ((GRGRupo de upo de AAnálisis de la nálisis de la CCardiopatía ardiopatía IIsquémica squémica AAguda)guda)
The GRACIA – 2 TrialThe GRACIA – 2 Trial ((GRGRupo de upo de AAnálisis de la nálisis de la CCardiopatía ardiopatía IIsquémica squémica AAguda)guda)
Randomised trial comparing Randomised trial comparing Primary PCI Primary PCI
versus versus Facilitated Intervention Facilitated Intervention
(TNK + Stenting) (TNK + Stenting) in patients with STEMI in patients with STEMI
Randomised trial comparing Randomised trial comparing Primary PCI Primary PCI
versus versus Facilitated Intervention Facilitated Intervention
(TNK + Stenting) (TNK + Stenting) in patients with STEMI in patients with STEMI
Francisco F. AvilésFrancisco F. Avilés(on behalf on the GRACIA group)(on behalf on the GRACIA group)
Francisco F. AvilésFrancisco F. Avilés(on behalf on the GRACIA group)(on behalf on the GRACIA group)
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GRACIA – 2 GRACIA – 2
BACKGROUNDBACKGROUNDGRACIA – 2 GRACIA – 2
BACKGROUNDBACKGROUND
Thrombolysis is widely available and easily applicable, but Thrombolysis is widely available and easily applicable, but
strongly limited by reopening failure and reocclusion strongly limited by reopening failure and reocclusion
Thrombolysis is widely available and easily applicable, but Thrombolysis is widely available and easily applicable, but
strongly limited by reopening failure and reocclusion strongly limited by reopening failure and reocclusion
Less than 50% of pts with STEMI achieve optimal arterial Less than 50% of pts with STEMI achieve optimal arterial
reopening plus effective myocardial reperfusion because of reopening plus effective myocardial reperfusion because of
the still limited use, availability and efficacy of current the still limited use, availability and efficacy of current
therapies therapies
Less than 50% of pts with STEMI achieve optimal arterial Less than 50% of pts with STEMI achieve optimal arterial
reopening plus effective myocardial reperfusion because of reopening plus effective myocardial reperfusion because of
the still limited use, availability and efficacy of current the still limited use, availability and efficacy of current
therapies therapies
Primary PCI is highly effective, but available for less than Primary PCI is highly effective, but available for less than
20% of pts with STEMI in Europe (Euro Heart Survey ACS). 20% of pts with STEMI in Europe (Euro Heart Survey ACS).
Few pts receive primary PCI within 2 hours of onset (6% in Few pts receive primary PCI within 2 hours of onset (6% in
the PAMI trial) the PAMI trial)
Primary PCI is highly effective, but available for less than Primary PCI is highly effective, but available for less than
20% of pts with STEMI in Europe (Euro Heart Survey ACS). 20% of pts with STEMI in Europe (Euro Heart Survey ACS).
Few pts receive primary PCI within 2 hours of onset (6% in Few pts receive primary PCI within 2 hours of onset (6% in
the PAMI trial) the PAMI trial)
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GRACIA – 2 GRACIA – 2
RATIONALE FOR FACILITATION RATIONALE FOR FACILITATION
(pharmacological reperfusion therapy + early planned PCI)(pharmacological reperfusion therapy + early planned PCI)
GRACIA – 2 GRACIA – 2
RATIONALE FOR FACILITATION RATIONALE FOR FACILITATION
(pharmacological reperfusion therapy + early planned PCI)(pharmacological reperfusion therapy + early planned PCI)
Pharmacological reopening prolongs time-window for Pharmacological reopening prolongs time-window for
definitive mechanical repair of the culprit artery (PCI more definitive mechanical repair of the culprit artery (PCI more
available) available)
Pharmacological reopening prolongs time-window for Pharmacological reopening prolongs time-window for
definitive mechanical repair of the culprit artery (PCI more definitive mechanical repair of the culprit artery (PCI more
available) available)
(1) Stone GW. Circulation 2001; (2) Lundergan CF. Am Heart J 2002; (3) Ross AM. JACC1999; (4) Hermann HC. JACC 2000; (4) Simoons ML. Lancet 1998; (6) Aviles FF. Eur Heart J 2003
Unlike in previous attemptsUnlike in previous attempts44, in the era of stents and modern , in the era of stents and modern
antiplatelets, early posthrombolysis PCI seems to be antiplatelets, early posthrombolysis PCI seems to be
feasible, feasible,
safe and beneficial (PACT safe and beneficial (PACT33, SPEED, SPEED55, GRACIA – 1, GRACIA – 166) )
Unlike in previous attemptsUnlike in previous attempts44, in the era of stents and modern , in the era of stents and modern
antiplatelets, early posthrombolysis PCI seems to be antiplatelets, early posthrombolysis PCI seems to be
feasible, feasible,
safe and beneficial (PACT safe and beneficial (PACT33, SPEED, SPEED55, GRACIA – 1, GRACIA – 166) )
TIMI 3 flow before primary PCI increases technical success TIMI 3 flow before primary PCI increases technical success
and benefits prognosis by enhancing myocardial salvage and benefits prognosis by enhancing myocardial salvage
and preserving LV function and preserving LV function11,2,3
TIMI 3 flow before primary PCI increases technical success TIMI 3 flow before primary PCI increases technical success
and benefits prognosis by enhancing myocardial salvage and benefits prognosis by enhancing myocardial salvage
and preserving LV function and preserving LV function11,2,3
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HYPOTHESISHYPOTHESIS
In pts with STEMI, the strategy of performing In pts with STEMI, the strategy of performing immediate thrombolysis followed by routine immediate thrombolysis followed by routine early catheterization and appropriate early catheterization and appropriate intervention is as available as thrombolysis intervention is as available as thrombolysis and as effective as primary PCIand as effective as primary PCI
HYPOTHESISHYPOTHESIS
In pts with STEMI, the strategy of performing In pts with STEMI, the strategy of performing immediate thrombolysis followed by routine immediate thrombolysis followed by routine early catheterization and appropriate early catheterization and appropriate intervention is as available as thrombolysis intervention is as available as thrombolysis and as effective as primary PCIand as effective as primary PCI
GRACIA – 2 GRACIA – 2 GRACIA – 2 GRACIA – 2
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PURPOSE PURPOSE
To compare the safety and efficacy of optimal To compare the safety and efficacy of optimal primary PCI versus a combined reperfusion primary PCI versus a combined reperfusion strategy designed to be easily applicable and strategy designed to be easily applicable and widely availablewidely available
PURPOSE PURPOSE
To compare the safety and efficacy of optimal To compare the safety and efficacy of optimal primary PCI versus a combined reperfusion primary PCI versus a combined reperfusion strategy designed to be easily applicable and strategy designed to be easily applicable and widely availablewidely available
GRACIA – 2 GRACIA – 2 GRACIA – 2 GRACIA – 2
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““OPTIMALOPTIMALPRIMARY PCIPRIMARY PCI””
(N=108)(N=108)
DIRECT PTCA – IRA** (stent / abciximab)
< 180 min
GRACIA-2GRACIA-2
(*) Adequate revascularization: revascularization of culprit artery or non-culprit arteries with severe stenosis threatening large areas of myocardium (**) IRA: Infarct Related Artery
TNK + Enoxaparin
Immediately
ADEQUATE REVASCULARIZATION*(stent / CABG)
3 – 12 hours
““FACILITATEDFACILITATEDINTERVENTION”INTERVENTION”
(N=104)(N=104) AMI / ST+(<12 hours)
RANDOMISATION
CLINICAL AND ANGIOGRAPHIC CLINICAL AND ANGIOGRAPHIC FOLLOW- UP FOLLOW- UP
AT 6 WEEKS & 6 MONTHSAT 6 WEEKS & 6 MONTHS
3 deaths3 deaths 6 deaths6 deaths
N = 103N = 103 N = 102N = 102
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GRACIA – 2 GRACIA – 2
CO – CO – PRIMARY PRIMARY ENDPOINTENDPOINTSS
Infarct sizeInfarct size (area under the CK-MB mass curve and cTnT (area under the CK-MB mass curve and cTnT release curve) release curve)
Myocardial reperfusion Myocardial reperfusion (% of pts with complete (% of pts with complete ∑∑STe resolution at STe resolution at 1, 3 and 6 hours) 1, 3 and 6 hours)
LV angiographic evolution at 6 weeksLV angiographic evolution at 6 weeks (volumes, LVEF, Wall Motion Index) (volumes, LVEF, Wall Motion Index)
CO – CO – PRIMARY PRIMARY ENDPOINTENDPOINTSS
Infarct sizeInfarct size (area under the CK-MB mass curve and cTnT (area under the CK-MB mass curve and cTnT release curve) release curve)
Myocardial reperfusion Myocardial reperfusion (% of pts with complete (% of pts with complete ∑∑STe resolution at STe resolution at 1, 3 and 6 hours) 1, 3 and 6 hours)
LV angiographic evolution at 6 weeksLV angiographic evolution at 6 weeks (volumes, LVEF, Wall Motion Index) (volumes, LVEF, Wall Motion Index)
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GRACIA-2 GRACIA-2
SECONDARY ENDPOINTSSECONDARY ENDPOINTS
Combined incidence of death, non-fatal myocardial Combined incidence of death, non-fatal myocardial infarction, or ischaemia-driven revascularization infarction, or ischaemia-driven revascularization at 6 weeks and 6 months at 6 weeks and 6 months
Incidence of bleeding complications and non-cardiac Incidence of bleeding complications and non-cardiac events at 6 weeks and 6 months events at 6 weeks and 6 months
SECONDARY ENDPOINTSSECONDARY ENDPOINTS
Combined incidence of death, non-fatal myocardial Combined incidence of death, non-fatal myocardial infarction, or ischaemia-driven revascularization infarction, or ischaemia-driven revascularization at 6 weeks and 6 months at 6 weeks and 6 months
Incidence of bleeding complications and non-cardiac Incidence of bleeding complications and non-cardiac events at 6 weeks and 6 months events at 6 weeks and 6 months
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GRACIA – 2GRACIA – 2 GRACIA – 2GRACIA – 2
212 patients212 patients
July 2002 – March 2003July 2002 – March 2003
15 Centres (Spain & Portugal)15 Centres (Spain & Portugal)
212 patients212 patients
July 2002 – March 2003July 2002 – March 2003
15 Centres (Spain & Portugal)15 Centres (Spain & Portugal)
H. Clínico-Universitario, Valladolid (FF Avilés)
H. P. Del Río Hortega, Valladolid (J Blanco, JJ Sanz)
H. Río Carrión, Palencia (J López Mesa)
H. Juan Canalejo, A Coruña (A Castro, N Vázquez)
H. Meixoeiro (MEDTEC), Vigo (J Golicolea)
H. Miguel Servet, Zaragoza (I Calvo)
Complejo Hospitalario, León (F Fernández V)
H. Clínico de San Carlos, Madrid (R A Hernández)
H. Virgen de la Salud, Toledo (J Moreu)
H. U. Virgen del Rocío, Sevilla (L Díaz de la Llera)
H. U. V. de la Victoria, Málaga (J Alonso B)
H. Rafael Méndez, Lorca-Murcia (S. Nicolás)
H. C. U. Valencia (J Sanchís)
H. Los Arcos, San Javier-Murcia (F.Martinez)
H. Fernando Fonseca, Amadora, Portugal (P. Abreu)
H. Clínico-Universitario, Valladolid (FF Avilés)
H. P. Del Río Hortega, Valladolid (J Blanco, JJ Sanz)
H. Río Carrión, Palencia (J López Mesa)
H. Juan Canalejo, A Coruña (A Castro, N Vázquez)
H. Meixoeiro (MEDTEC), Vigo (J Golicolea)
H. Miguel Servet, Zaragoza (I Calvo)
Complejo Hospitalario, León (F Fernández V)
H. Clínico de San Carlos, Madrid (R A Hernández)
H. Virgen de la Salud, Toledo (J Moreu)
H. U. Virgen del Rocío, Sevilla (L Díaz de la Llera)
H. U. V. de la Victoria, Málaga (J Alonso B)
H. Rafael Méndez, Lorca-Murcia (S. Nicolás)
H. C. U. Valencia (J Sanchís)
H. Los Arcos, San Javier-Murcia (F.Martinez)
H. Fernando Fonseca, Amadora, Portugal (P. Abreu)
RecruitmentRecruitment RecruitmentRecruitment
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MAIN SPONSORSMAIN SPONSORS
Spanish Ministry of Health*Spanish Ministry of Health*
Guidant**Guidant**
Lilly**Lilly**
MAIN SPONSORSMAIN SPONSORS
Spanish Ministry of Health*Spanish Ministry of Health*
Guidant**Guidant**
Lilly**Lilly**
GRACIA – 2GRACIA – 2 GRACIA – 2GRACIA – 2
(*) Cooperative Network for Cardiovascular Research [Instituto de Salud Carlos III]; (**) Unrestricted grant
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GRACIA – 2 GRACIA – 2 GRACIA – 2 GRACIA – 2
Primary PCI Primary PCI (108 pts)(108 pts)
Facilitated PCIFacilitated PCI(104 pts)(104 pts) pp
Age Age 6363++1313 6262++12 12 0.30.3
Male Male 82%82% 78%78% 0.60.6
Prior AnginaPrior Angina 25%25% 15%15% 0.10.1
Prior PCIPrior PCI 9%9% 2%2% 0.060.06
DiabetesDiabetes
HypertensionHypertension
HyperlipidaemiaHyperlipidaemia
SmokingSmokingFamily historyFamily history
27%27%
39%39%
40%40%
45%45%
18%18%
23%23%
34%34%
41%41%
50%50%
15%15%
0.490.49
0.750.75
0.410.41
0.480.48
0.510.51
Anterior MIAnterior MI 50%50% 45%45% 0.470.47
Baseline Clinical Baseline Clinical Baseline Clinical Baseline Clinical
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GRACIA – 2 GRACIA – 2 GRACIA – 2 GRACIA – 2
85%89%
75%79%
66% 68%
91%97%
87%
Adjunctive medical treatmentAdjunctive medical treatmentAdjunctive medical treatmentAdjunctive medical treatment
64%67%
23%
Thienopyridines Aspirin ACE Inh. Statins AbciximabB - Blockers
p = 0.001
Primary Primary FacilitatedFacilitated
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GRACIA – 2 GRACIA – 2 GRACIA – 2 GRACIA – 2
Time intervals (mean)Time intervals (mean)Time intervals (mean)Time intervals (mean)
PrimaryPrimary FacilitatedFacilitated
0
3
6
9
12
Onset torandomisation
Randomisation toCatheterisation
Onset toCatheterisation
Ho
urs
3.18+1.9 hh 3.20+2.05 hh
1.08+3.7 hh
5.89+3.7 hh4.19+9.06 hh
9.06+4.19 hh
p = 0.82
p = 0.001
p = 0.001
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GRACIA – 2 GRACIA – 2 GRACIA – 2 GRACIA – 2
Baseline culprit artery flowBaseline culprit artery flowTIMI flow grade (TFG) & Corrected TIMI Frame Count (CTFC)TIMI flow grade (TFG) & Corrected TIMI Frame Count (CTFC)11
Baseline culprit artery flowBaseline culprit artery flowTIMI flow grade (TFG) & Corrected TIMI Frame Count (CTFC)TIMI flow grade (TFG) & Corrected TIMI Frame Count (CTFC)11
Primary (4.2Primary (4.2++9.1 hh from onset)9.1 hh from onset)
TFG 3 TFG 2 TFG 1/0 Mean CTFC (only TFG 2/3)
p=0.005
p=0.047
p=0.008
p=0.034
20.920.9++13.013.0
30.630.6++20.520.5
14%14% 15%15%23%23%
73%73%
8%8%
59%59%
FacilitatedFacilitated (9.1 (9.1++4.2 hh from onset)4.2 hh from onset)
(1) Gibson CM et al. Circulation 1996
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IRA locationIRA location
LAD RCA CX LMCA
47%47%44%44%
44%44%
45%45%
5%5%
11%11%
2%2%0%0%
CAD extensionCAD extension(vessels with (vessels with >>50% QCA50% QCA stenosis)stenosis)
GRACIA – 2 GRACIA – 2 GRACIA – 2 GRACIA – 2
Baseline AngiographyBaseline AngiographyBaseline AngiographyBaseline Angiography
PrimaryPrimary FacilitatedFacilitated
56,0%
28,0%
14,0%
2,0%
55%
30%
3%
11%
1 vessel 2 vessel 3 vessel 0 vessel
(P=0.82)
(P=0.37)
(P=0.08)(P=0.01)
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GRACIA – 2 GRACIA – 2 GRACIA – 2 GRACIA – 2
Angiography (culprit lesion)Angiography (culprit lesion)Angiography (culprit lesion)Angiography (culprit lesion)
PRIMARYPRIMARY(4.19+9.1 hh from onset)(4.19+9.1 hh from onset)
FACILITATEDFACILITATED (4.19+9.1 hh from onset)(4.19+9.1 hh from onset)
pp
Reference PreReference Pre 2.582.58++0.9 mm0.9 mm 2.672.67++0.82 mm 0.82 mm 0.520.52
MLD pre MLD pre 0.440.44++0.67 mm0.67 mm 1.061.06++0.660.66 <0.001<0.001
% stenosis Pre% stenosis Pre 84.884.8++59.7%59.7% 59.759.7++23.8%23.8% <0.01<0.01
Lesion Length Lesion Length 8.28.2++3.7 mm 3.7 mm 7.97.9++3.4 mm3.4 mm 0.680.68
CalcificationCalcification 6%6% 2%2% 0.480.48
ThrombusThrombus 70%70% 43%43% 0.0010.001
Success (angio)Success (angio) 85%85% 89%89% 0.600.60
Reference PostReference Post 3.093.09++0.62 mm0.62 mm 3.373.37++2.03 mm2.03 mm 0.240.24
MLD PostMLD Post 2.992.99++2.9 mm2.9 mm 2.962.96++1.671.67 0.940.94
% Stenosis Post% Stenosis Post 16.316.3++19.8%19.8% 11.411.4++5.7%5.7% 0.0340.034
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GRACIA – 2 GRACIA – 2 GRACIA – 2 GRACIA – 2
Final treatmentFinal treatmentFinal treatmentFinal treatment
(*) Conservative treatment due to non-significant CAD or CAD unsuitable for revascularization
PrimaryPrimary
FacilitatedFacilitated
3%1%
8%16%
89%83%
9%
20%
CABG CULPRITPCI
ASSOCIATEDNON-CULPRIT PCI
NOMECHANICAL
INTERVENTION*
p = 0.64
p = 0.07p = 0.02
p = 0.19
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GRACIA – 2GRACIA – 2GRACIA – 2GRACIA – 2
ST – Segment Elevation RecoveryST – Segment Elevation RecoveryST – Segment Elevation RecoveryST – Segment Elevation Recovery
Percentage of pts with “Complete”Percentage of pts with “Complete”** ∑STe Recovery ∑STe RecoveryPercentage of pts with “Complete”Percentage of pts with “Complete”** ∑STe Recovery ∑STe Recovery
24%
47%43%
15%
46%
61%
0%
20%
40%
60%
80%
1 hour 3 hours 6 hours
P= 0.19
P= 0.83
P= 0.03
PrimaryPrimary FacilitatedFacilitated
(*) [Schroeder R. JACC 1994]: (*) [Schroeder R. JACC 1994]: >> 70% reduction of the pre-reperfusion total deviation (∑STe) 70% reduction of the pre-reperfusion total deviation (∑STe)(*) [Schroeder R. JACC 1994]: (*) [Schroeder R. JACC 1994]: >> 70% reduction of the pre-reperfusion total deviation (∑STe) 70% reduction of the pre-reperfusion total deviation (∑STe)
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GRACIA – 2GRACIA – 2GRACIA – 2GRACIA – 2Infarct sizeInfarct sizeInfarct sizeInfarct size
0,190,59
4,15
3,19 3,36
4,17
2,98
2,61
4,5
ng
/dl
0.0
3,06
2,23
Primary
Facilitated
days
0 1 2 3 4
cTnT releasecTnT release CK-MB massCK-MB mass
253,92
171,91
106,11
17,62
211,06
27,57 12,42
20,0834,62
58,56
229,12
91,68
160,87
15,5121,96
35,03
56,96
229,94
Primary
Facilitated
300
0 hours
0 12 24 48
Area under the curveArea under the curve PRIMARYPRIMARY FACILITATEDFACILITATED pp
cTnTcTnT 275.5275.5++211.4211.4 241.8241.8++155.5 155.5 0.520.52
CK-MB mass CK-MB mass 4768.304768.30++3734.03734.0 4602.014602.01++3371.23371.2 0.760.76
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GRACIA – 2GRACIA – 2
LV evolution at 6 weeksLV evolution at 6 weeksGRACIA – 2GRACIA – 2
LV evolution at 6 weeksLV evolution at 6 weeks
PRIMARYPRIMARY FACILITATEDFACILITATED PP
LVEFLVEFBaseline Baseline
6-week FU 6-week FU ∆∆
52.552.5++14.3%14.3%
55.655.6++13.4%13.4%
3.23.2++11.811.8
53.453.4++9.9%9.9%
56.156.1++12.4%12.4%
3.43.4++11.811.8
0.70.7
0.90.9
0.90.9
Wall Motion Index (SD/chord)Wall Motion Index (SD/chord) Baseline Baseline
6-week FU6-week FU∆∆
-1.50-1.50++0.40.4
-1.10-1.10++0.60.6
0.420.42++0.670.67
-1.47-1.47++0.40.4
-1.24-1.24++0.460.46
0.240.24++0.500.50
0.70.7
0.10.1
0.090.09
EDLV volume index EDLV volume index ((ml/mml/m22)) Baseline Baseline
6-week FU 6-week FU ∆∆
126.5126.5++4141
139.8139.8++57.957.9
11.2111.21++37.7637.76
122.01122.01++4747
129.8129.8++54.054.0
13.2313.23++11.811.8
0.400.40
0.350.35
0.690.69
ESLV volume index ESLV volume index ((ml/mml/m22)) Baseline Baseline
6-week FU 6-week FU ∆∆
56.4356.43++25.0225.02
62.3262.32++35.735.7
5.285.28++21.08721.087
57.6257.62++25.8725.87
56.2356.23++31.9131.91
-2.07-2.07++28.3028.30
0.920.92
0.350.35
0.160.16
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GRACIA – 2GRACIA – 26-week clinical outcome6-week clinical outcomeGRACIA – 2GRACIA – 26-week clinical outcome6-week clinical outcome
Cardiac EventsCardiac EventsCardiac EventsCardiac Events
PrimaryPrimary PrimaryPrimary FacilitatedFacilitatedFacilitatedFacilitated
12%
6%
1% 1%
6%
9%9%
3%2%
1%
7%
11%
0%
5%
10%
15%
CombinedCombinedclinical clinical
endpoint*endpoint*(10.5%)(10.5%)
CombinedCombinedclinical clinical
endpoint*endpoint*(10.5%)(10.5%)
SurgerySurgery(1%)(1%)
SurgerySurgery(1%)(1%)
IschaemiaIschaemiadriven PCIdriven PCI
(6.5%)(6.5%)
IschaemiaIschaemiadriven PCIdriven PCI
(6.5%)(6.5%)
Re-admissionRe-admission(4.5%)(4.5%)
Re-admissionRe-admission(4.5%)(4.5%)
DeathDeath((4.5%)4.5%)DeathDeath((4.5%)4.5%)
********
********
********
********
** p = NS** p = NS** p = NS** p = NS********
********
Re-infarctionRe-infarction(1(1.5.5%)%)
Re-infarctionRe-infarction(1(1.5.5%)%)
(*) Combined clinical EP: death, nonfatal MI, or ischemia-driven revascularization(*) Combined clinical EP: death, nonfatal MI, or ischemia-driven revascularization(*) Combined clinical EP: death, nonfatal MI, or ischemia-driven revascularization(*) Combined clinical EP: death, nonfatal MI, or ischemia-driven revascularization
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GRACIA – 2GRACIA – 26-week clinical outcome6-week clinical outcomeGRACIA – 2GRACIA – 26-week clinical outcome6-week clinical outcome
Bleeding & vascular complicationsBleeding & vascular complicationsBleeding & vascular complicationsBleeding & vascular complications
(*) Major bleeding or vascular complication: intracranial haemorrhage, or any complications that prolonged stay or needed (*) Major bleeding or vascular complication: intracranial haemorrhage, or any complications that prolonged stay or needed surgery / transfusion surgery / transfusion
(*) Major bleeding or vascular complication: intracranial haemorrhage, or any complications that prolonged stay or needed (*) Major bleeding or vascular complication: intracranial haemorrhage, or any complications that prolonged stay or needed surgery / transfusion surgery / transfusion
PrimaryPrimary PrimaryPrimary FacilitatedFacilitatedFacilitatedFacilitated
AnyComplication
6.7%
3.0%
0.0%
10.3%
2.0%1.0%
0%
5%
10%
MajorComplications (ICH included)*
IntracranialHaemorrhage
(ICH)
p=0.45
p=0.97
p=0.99
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Catheterization plus adequate revascularization within Catheterization plus adequate revascularization within 3 – 12 hours of immediate facilitation with TNK seems to be 3 – 12 hours of immediate facilitation with TNK seems to be as safe as optimal primary PCI (stent & GP IIb/IIIa inhibitors) as safe as optimal primary PCI (stent & GP IIb/IIIa inhibitors)
GRACIA – 2GRACIA – 2GRACIA – 2GRACIA – 2
CONCLUSIONSCONCLUSIONSCONCLUSIONSCONCLUSIONS
These results suggest that both strategies are similarly These results suggest that both strategies are similarly effective in restoring myocardial perfusion, preserving left effective in restoring myocardial perfusion, preserving left ventricular size & function and beneficing clinical outcome ventricular size & function and beneficing clinical outcome
If this equivalence is confirmed in large studies clinically If this equivalence is confirmed in large studies clinically focused, the proportion of patients with STEAMI who focused, the proportion of patients with STEAMI who can benefit from early PCI could increase dramatically can benefit from early PCI could increase dramatically